The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee applies aseptic techniques while working in controlled and classified environments, which require cleanroom gowning and some aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

Follow work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities and maintain quality data while meeting production goals and timelines and minimizing downtime/delays. Work instructions include but are not limited to:
Weighing and dispensing of materials
Media and buffer preparation
Operation of filtration systems (such as dead end filtration, depth filtration, tangential flow filtration)
Inoculation, fermentation, harvest, and homogenization of cytokine cells
Setup and operation of chromatography columns
Aseptic final filtration of intermediates and drug substances
Monitor product for quality output using PLC controls, HMI interfacing, integrity testing, and in process testing (pH, Conductivity, and Spectroscopy).
Properly handle and discard hazardous materials (i.e, buffers, chemicals, etc.) in accordance with EHS guidelines. Remove used and soiled materials from manufacturing areas.
Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing.
Verify raw materials and commodities; accurately enter raw material and commodities data in MES on daily basis
Completes Batch Records and other cGMP documentation accurately and in a timely manner.
Reports nonconformances or events that arise during the shift to the Supervisor
Complies with all safety, cGMP and Company policies, practices and procedures.
Performs other functions as required or assigned

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Kashiv BioSciences, LLC

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